<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20230426057999N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-31</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of using simulator software on students' learning</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of ventilator training with simulator and electronic flash card on knowledge and performance of nursing students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69798</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Blocked, allocation concealment method: packet in packet, random sequence will be determined using Randomizer.org site for two study groups. The random sequence will be in blocks of four without permutation. To create a random sequence according to the two groups and the number of studied samples, the random sequence will be extracted from this site. This sequence is written on small cards and kept in a closed envelope. Whenever one of the research units is found to meet the study criteria, the envelope is opened and based on the code on the sheet (the first intervention group and the second intervention group) ) will be entered into the relevant group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Investigating the impact of education on students' knowledge and performance.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: flash card software training in 7th and 8th semester nursing students who have not completed ICU training. The content of the electronic flash card software is based on the EDP ventilator catalog, the questions will be written on the flash card and their answers will be written on the back of the flash card so that the student can study at the designated time intervals. During 10 days, students will receive the necessary training based on the schedule that includes how to study and work with the software and is provided to them. Then, at the end of 10 days, the test will be done from this group, and a month later, the test will be done again in order to preserve the information. Intervention 2: The second intervention group: training simulator software in 7th and 8th semester nursing students who have not completed ICU training. The educational content of the simulator software is based on the EDP ventilator catalog, and the design of the simulator software is such that the student will feel that he is in the real environment of working with the ventilator, so that all the actions that are taken in the real environment when facing the ventilator does will also do in this software, among these actions can be mentioned the selection of breathing modes, their adjustment, how to manage alarms, etc. During 10 days, students will receive the necessary training based on the schedule that includes how to study and work with the software and is provided to them. Then, at the end of 10 days, the test will be done from this group, and a month later, the test will be done again in order to preserve the information.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vahid Ghorbani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Hossein St. 5, Zebashahr town</address>
        <city>Tabas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9791774531</zip>
        <telephone>+98 56 3283 3095</telephone>
        <email>ghorbaniv4001@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Vahid Ghorbani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Hossein St. 5, Zebashahr town</address>
        <city>Tabas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9791774531</zip>
        <telephone>+98 56 3283 3095</telephone>
        <email>ghorbaniv4001@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>7th semester nursing students and those 8th semester nursing students who did not complete ICU internship
informed consent
no experience of working as a student in the intensive care unit</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Acquaintance with the ventilator
Work experience in Intensive departments
Apprenticeship in the Intensive department</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: flash card software training in 7th and 8th semester nursing students who have not completed ICU training. The content of the electronic flash card software is based on the EDP ventilator catalog, the questions will be written on the flash card and their answers will be written on the back of the flash card so that the student can study at the designated time intervals. During 10 days, students will receive the necessary training based on the schedule that includes how to study and work with the software and is provided to them. Then, at the end of 10 days, the test will be done from this group, and a month later, the test will be done again in order to preserve the information.</i_keyword>
      <i_keyword>The second intervention group: training simulator software in 7th and 8th semester nursing students who have not completed ICU training. The educational content of the simulator software is based on the EDP ventilator catalog, and the design of the simulator software is such that the student will feel that he is in the real environment of working with the ventilator, so that all the actions that are taken in the real environment when facing the ventilator does will also do in this software, among these actions can be mentioned the selection of breathing modes, their adjustment, how to manage alarms, etc. During 10 days, students will receive the necessary training based on the schedule that includes how to study and work with the software and is provided to them. Then, at the end of 10 days, the test will be done from this group, and a month later, the test will be done again in order to preserve the information.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Examining the knowledge of nursing students in the field of ventilator training. Timepoint: Checking knowledge and performance before starting the study and on the 10th day of the study. Method of measurement: Examination of knowledge according to the questionnaire made by the researcher.</prim_outcome>
      <prim_outcome>Examining the performance of nursing students in the field of ventilator training. Timepoint: Performance review before the start of the study and on the 10th day of the study. Method of measurement: examination of performance based on the checklist made by the researcher.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-21</approval_date>
        <contact_name>Mashhad University of Medical Sciences</contact_name>
        <contact_address>5 Imam Hossein Street, Zibashahr Town Tabas South Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
